CE-MDR and FDA 510(k) Cleared Kyphoplasty Balloon Catheter 8G 20mm
The Changmei Kyphoplasty Balloon Catheter KB0120 is a single-use, inflatable bone tamp designed for percutaneous balloon kyphoplasty (PKP). This 8G model features a 20mm distance between radiopaque markers, a maximum inflation volume of 6 cc, and a constrained burst pressure of ≥400 PSI, making it a reliable choice for reducing vertebral fractures and creating cavities for PMMA bone cement injection.
Key Selling Points
Certified Safety: CE-MDR marked (EU 2017/745) and FDA 510(k) cleared (K223709), ensuring compliance with global regulatory standards. Source: product description, certifications.
High Burst Pressure: Withstands ≥400 PSI, reducing intraoperative burst risk for reliable performance. Source: product parameters.
Optimized Balloon Volume: 6 cc maximum inflation volume enables effective vertebral height restoration with controlled cavity creation. Source: product parameters.
Biocompatible TPU Construction: Medical-grade thermoplastic polyurethane with four-wing pleating delivers radial support and smooth passage through trocar. Source: material description.
Sterile Single-Use: EO-sterilized with 3-year shelf life, ensuring safe and convenient use. Source: product description.
Technical Specifications
Parameter
Value
Model
KB0120
Size/Type
8G
Distance of Two Radiopaque Markers
20 mm
Channel ID
≥3.65 mm
Overall Length
315 mm
Maximum Volume
6 cc
Constrained Burst Pressure
≥400 PSI
Models and Options
The KB0120 is part of the Changmei 8G PKP catheter family, which also includes KB0210 (10mm) and KB0150 (15mm). These models provide options for different vertebral body sizes and fracture patterns.
Materials and Structure
Constructed from medical-grade thermoplastic polyurethane (TPU) on a PU shaft, with tantalum radiopaque markers and a stainless-steel stylet for pushability. The four-wing pleating design ensures uniform expansion and cavity creation.
Applications
Indicated for minimally invasive treatment of painful vertebral compression fractures caused by osteoporosis, trauma, or neoplasia, including spinal metastases and multiple myeloma. Also used for symptomatic vertebral hemangiomas.
Customization
OEM/ODM customization is available. MOQ for standard in-stock products is 10 sets; customized orders have negotiable minimum quantities based on specific requirements.
Case Study
Clinical use in VCFs with egg shell technique in Kuwait demonstrates the system's effectiveness in restoring vertebral height and correcting kyphotic deformity.
FAQ
Q: What is the shelf life of the KB0120?
A: The KB0120 is EO-sterilized and validated for a 3-year shelf life.
Q: What is the MOQ?
A: MOQ is 10 sets for standard in-stock products; negotiable for OEM/ODM.
Q: What certifications does the KB0120 hold?
A: It is CE-MDR marked and FDA 510(k) cleared (K223709), with ISO 13485 quality management.
Q: Can the KB0120 be used with other Changmei tools?
A: Yes, it is designed to pair with the KT-00-01 8G tool kit and BI-20A-10 balloon inflator.
Q: What is the delivery method?
A: Delivery methods include EXW, FOB, and CIF.
Inquiry Information
For pricing and orders, contact Mark at cyz@czmed.com or +86 138-1368-7682 (WhatsApp available).
